The Recall Desk
HighFDA (Devices)·Z-2517-2020·Announced 2020-07-15

Kentec Medical Recalls ENFit Polyurethane and Silicone Feeding Tubes

Kentec Medical is recalling 2,130 ENFit feeding tubes because the plastic tethered closure cap may fracture or break, potentially delaying patient care.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the source describes a risk-of-harm product (delayed feeding/medication and radiation exposure) where no specific injuries or illnesses have been reported yet, fitting the 'High' severity criteria.

Plain-English summary

Kentec Medical, Inc. is recalling 2,130 units of Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes (Catalog number ENF-80P-50). The affected units are sterile, single-use enteral feeding tubes with a size of 8 fr and a length of 50 cm. The specific lot number is KS1904004.

The recall was initiated because the plastic tethered closure cap on the feeding tubes may possibly fracture or break. This defect could lead to two potential health hazards: first, enteral feeding and medication administration could be delayed until a replacement tube is placed; second, patients could be unnecessarily overexposed to radiation if multiple x-rays are required to confirm the placement of a new tube.

The affected products were distributed in California, Iowa, and Virginia. Consumers and healthcare facilities should stop using the affected tubes and contact Kentec Medical for instructions on replacement or return.

The recalled product

Product
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-80P-50 (8 fr. 50 cm ENFit Enteral Feeding Tube).
Manufacturer
Kentec Medical, Inc
Category
Medical Device — Enteral Feeding Tubes
Hazard
Affected units
2,130

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number: KS1904004

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 7 recalled by Kentec Medical, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Related recalls

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